Zetz v. Bos. Scientific Corp.

• Decision Date: 18 July 2019
• Docket Number: Case No. 1:19-cv-00451-AWI-SAB
• Parties: Autumn ZETZ and Eric Zetz, Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant.
• Court: U.S. District Court — Eastern District of California

398 F.Supp.3d 700

Autumn ZETZ and Eric Zetz, Plaintiffs,

v.BOSTON SCIENTIFIC CORPORATION, Defendant.

Case No. 1:19-cv-00451-AWI-SAB

United States District Court, E.D. California.

Signed July 18, 2019

Christopher Dolan, Jeremy Jessup, Dolan Law Firm, San Francisco, CA, for Plaintiffs.

Victoria Patricia McLaughlin, Eva Marie Mannoia Weiler, Shook Hardy & Bacon, Irvine, CA, for Defendant.

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO DISMISS

Anthony W. Ishii, SENIOR DISTRICT JUDGE

I. Background¹

Autumn Zetz suffered from stress urinary incontinence

. To treat her condition, Ms. Zetz was surgically implanted in 2008 with a pelvic mesh device called the Obtryx Sling. The Obtryx Sling ("Product") is a surgical mesh device that was manufactured, packaged, labeled, marketed, sold, and distributed by Boston Scientific Corporation ("Boston Scientific") as a treatment for stress urinary incontinence. The Product contains monofilament polypropylene mesh.

After Ms. Zetz was implanted with the Product, Ms. Zetz experienced serious adverse health effects, including pudendal neuralgia

, catastrophic pain syndrome, bladder dysfunction, dyspareunia, and loss of mobility. These adverse effects occurred because, at least in part, the polypropylene in the Product is biologically incompatible with human tissue, thereby making the Product defective. In addition to Ms. Zetz, many other women who were implanted with the Product experienced serious adverse effects, including chronic pain and functional disabilities.

Prior to Ms. Zetz and many other women being implanted with the Product, Boston Scientific knew about but ignored and downplayed the Product's health risks and defects. Yet, to this day, Boston Scientific continues to falsely market and sell the Product as a safe, effective, and reliable medical product that is safer and more effective than available feasible alternative treatments for stress urinary incontinence

.

Ms. Zetz and her husband, Eric Zetz (collectively "Plaintiffs"), sued Boston Scientific, pleading ten causes of action: (1) strict liability for failure to warn; (2) strict liability for manufacturing defect; (3) strict liability for design defect; (4) negligence; (5) breach of implied warranty; (6) breach of express warranty; (7) fraudulent misrepresentation; (8) negligent misrepresentation; (9) fraudulent concealment; and (10) loss of consortium. Then, pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, Boston Scientific moved to dismiss Plaintiffs' following causes of action: failure to warn under the strict liability and negligence theories; manufacturing defect under the strict liability and negligence theories; design defect under the strict liability theory; breach of implied warranty; fraudulent misrepresentation; negligent misrepresentation; and fraudulent concealment. Plaintiffs filed an opposition to the motion, and Boston Scientific filed a reply.

II. Legal Standard

Under Rule 12(b)(6), a cause of action may be dismissed because of the plaintiff's "failure to state a claim upon which relief can be granted." Fed. Rule Civ. Proc. 12(b)(6). A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir. 2011) ; Johnson v. Riverside Healthcare Sys., 534 F.3d 1116, 1121 (9th Cir. 2008). In reviewing a complaint under Rule 12(b)(6), all allegations of material fact are taken as true and construed in the light most favorable to the non-moving party. Faulkner v. ADT Sec. Servs., 706 F.3d 1017, 1019 (9th Cir. 2013). However, complaints that offer no more than "labels and conclusions" or "a formulaic recitation of the elements of action will not do." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The Court is not required "to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences." Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1145 n.4 (9th Cir. 2012) ; Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). To avoid a dismissal under Rule 12(b)(6), "a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. A claim has facial plausibility when the plaintiff pleads factual content that allows the court draw the reasonable inference that the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The Ninth Circuit has distilled the following principles from Iqbal and Twombly: (1) to be entitled to the presumption of truth, allegations in a complaint or counterclaim may not simply recite the elements of a cause of action, but must contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively; (2) the factual allegations that are taken as true must plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation. Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011). In assessing a motion to dismiss, courts may consider documents attached to the complaint, documents incorporated by reference in the complaint, or matters of judicial notice. Dichter-Mad Family Partners, LLP v. United States, 709 F.3d 749, 761 (9th Cir. 2013). If a motion to dismiss is granted, then the "district court should grant leave to amend even if no request to amend the pleading was made, unless it determines that the pleading could not possibly be cured by the allegation of other facts." Henry A. v. Willden, 678 F.3d 991, 1005 (9th Cir. 2012).

III. Discussion

1. Failure to warn under strict liability and negligence theories

Boston Scientific argues that Plaintiffs failed to state a claim for failure to warn under the strict liability and negligence theories in light of California's learned intermediary doctrine "[t]o the extent such claims rely on a duty to warn anyone other [than] Ms. Zetz's prescribing physician." Doc. No. 6-1. California's learned intermediary doctrine holds that a manufacturer of prescription drugs or medical devices satisfies its duty to warn when it provides adequate warnings to the prescribing physician, as opposed to the patient. See Carlin v. Superior Court, 13 Cal. 4th 1104, 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (1996) ("[I]n the case of prescription drugs, the duty to warn runs to the physician, not to the patient."); Brown v. Superior Court, 44 Cal. 3d 1049, 1061 n.9, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) ("It is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician."). The rationale for the learned intermediary doctrine goes as follows:

(1) The doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer's control, on the part of the doctor. (2) Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug, thereby jeopardizing his life. (3) It would be virtually impossible for a manufacturer to comply with the duty of direct warning, as there is no sure way to reach the patient.

Carmichael v. Reitz, 17 Cal. App. 3d 958, 989, 95 Cal.Rptr. 381 (1971). The learned intermediary doctrine applies to implanted medical devices, Bigler-Engler v. Breg, Inc., 7 Cal. App. 5th 276, 320, 213 Cal.Rptr.3d 82 (2017), and it covers failure to warn claims under both the strict liability theory and the negligence theory. Saavedra v. Eli Lily & Co., 2013 WL 6345442, *3, 2013 U.S. Dist. LEXIS 173055, *8 (C.D. Cal. Feb. 26, 2013).

Here, Plaintiffs sufficiently alleged that Boston Scientific failed to provide adequate warnings to the learned intermediaries, which would include Ms. Zetz's physicians. The following allegations from the complaint illustrate this point:

31. The Obtryx sling was unreasonably susceptible to shrinkage and contraction inside the body. Defendant should have known of this serious risk and warned physicians and patients.

35. Further, while some of the problems associated with the Obtryx sling were made known to physicians, the magnitude and frequency of these problems were not disclosed and were hidden from physicians.

36. Contrary to Defendants' representations and marketing to the medical community and to the patients themselves, the Obtryx sling has high rates of failure, injury, and complications, fails to perform as intended, requires frequent and often debilitating re-operations, and has caused severe and irreversible injuries, conditions, and damages to a significant number of women, including Plaintiff, making them defective under the law.

44. Defendants knowingly provided incomplete and insufficient training and information to physicians regarding the use of the Obtryx and the aftercare of patients implanted with the Obtryx.

63. The risk of serious injuries was known or should have been known to Defendants, but in spite of these risks, Defendants deliberately concealed these risks and, instead, represented that the product was safe and effective and continued to market the Obtryx to physicians and patients, including Plaintiffs, without adequate warnings.

Doc. 1-1 (emphasis added).

It is true, as Boston Scientific points out, that the complaint also alleges that Boston Scientific failed to provide adequate warnings to Plaintiffs. To be clear, ...